Refractive Error, Myopia
Conditions
Brief summary
This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.
Interventions
DEVICEsenofilcon A
silicone hydrogel contact lens
DEVICEbalafilcon A
silicone hydrogel contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are of legal age (18 years) and capacity to volunteer. 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. 6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). 7. They have successfully worn contact lenses within six months of starting the study.
Exclusion criteria
1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. They are pregnant or lactating. 8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV). 10. They have diabetes. 11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A). | after 4 weeks of lens wear | Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Completed study population | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 24.4 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Time frame: after 4 weeks of lens wear
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A). | 4.0074 Units on a scale | Standard Error 0.2008 |
| Balafilcon A | Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A). | 2.8438 Units on a scale | Standard Error 0.1972 |
Comparison: Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.95% CI: [0.789, 1.1636]Mixed Models Analysis